Senior Software Quality Engineer, Design Assurance

Stryker is hiring a Senior Software Quality Engineer, Design Assurance to support our Medical’s Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) to execute on Digital Health projects as a software design quality assurance engineer for pre-market new product development projects. 

Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed.

What you will do:

• Designed and tested prototypes and components, applying engineering principles to meet sub-system requirements and support product development.

• Conducted root-cause analysis and problem-solving, evaluating solutions against technical and regulatory criteria.

• Translated design inputs into engineering specifications, contributing to component-level and system-level architecture and documentation.

• Developed software components, estimated development resources, and led code reviews to ensure alignment with design standards and best practices.

• Collaborated cross-functionally with R&D, Quality, Regulatory, and Marketing teams to drive project success and ensure compliance with design controls and risk management processes.

• Created and maintained engineering documentation, including Design History Files, in accordance with medical device regulatory standards.

• Demonstrated strong understanding of clinical use cases, customer needs, and product requirements to inform design decisions.

• Adapted quickly to new systems and processes, showing initiative, ownership, and the ability to prioritize tasks with minimal supervision.

What you need:

Required: 

• Bachelor’s degree in a science or engineering. 

• Minimum of 2+ years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), Software Engineering, Information Technology, Healthcare IT or Systems Engineering.

Preferred:  

• Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.

• Experience working through software lifecycle processes (Agile SAFe/Waterfall).   

• Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.

• Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar, demonstrating strong technical skills

• Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions.

• Knowledge from using Application Lifecycle Management /Traceability tools.